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External Manufacturing, Associate Director

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Saturday, May 25, 2024

Job Description

General Summary:

The Associate Director is responsible for managing the operations of Vertex’s external commercial network of Drug Product Intermediate manufacturing, working in the External Manufacturing Operations team. Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain team’s role in ensuring that the company effectively and efficiently delivers medicines to patients. The Associate Director provides vision, leadership, and both strategic and enterprise thinking in the management of the external partners. This leader will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges. The Associate Director of External Manufacturing Operations reports directly to the Vice President, External Manufacturing Operations and may lead a diverse team of direct reports, or dotted line staff of external manufacturing leaders for Vertex’s various CDMO relationships. This position will be based in Vertex’s corporate headquarters in Boston, MA. This role will be accountable for all Drug Product Intermediate external commercial manufacturing operations activities globally for small molecule. This role will partner closely with colleagues across Vertex to ensure seamless supply of all Drug Product Intermediate commercial products. The candidate will be in a hybrid role (3 days/week onsite), with travel to CDMO sites as necessary.

Key Duties and Responsibilities:

  • Acts as main point of contact for CDMO(s) including leader of CDMO working teams and strategic business review chairperson.
  • Responsible for Long Term Strategic supplier management and accountable for Supplier Relationship Management (SRM) and SRM related processes for given CDMOs.
  • Responsible for driving execution of Drug Product Intermediate production plans: Provide operational oversight and troubleshooting support to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management).
  • Responsible for driving execution of the production plan at CDMO. (PO through delivery).
  • Partners with MS&T, Quality and CMSC Strategy and Business Operations to champion a culture of quality with our CDMO’s and to ensure that all activities and documentation comply with regulatory requirements.
  • Establish a robust tracking and reporting process to monitor CDMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
  • Leads identification and resolution of business/contract issues (bring in legal, CMSC LT, Strategy +Bus Ops, Strategic Sourcing)
  • Partners with Vendor Management, Strategic Sourcing and Strategy and Business Operations to further develop our Supplier Relationship Management and Supplier Contracting Programs.
  • Partners with Global Supply Chain to develop long term manufacturing network strategy and to maintain a flexible, reliable, robust, and cost-effective manufacturing network.
  • Champions a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement
  • Ability to travel, national and international, up to 25%.

Knowledge and Skills:

  • Understanding of the science and technology underlying Drug Product Intermediate (spray dried dispersion) manufacturing as well as analytical techniques that support commercial manufacturing activities
  • Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, maintenance, and engineering
  • Strong knowledge of cGMP requirements
  • A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
  • Understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls
  • Excellent communication and interpersonal skills with the ability to work in strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor
  • Excellent team player and be able to build and sustain organization respect and trust at all levels
  • Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
  • Resilient and able to work well in a demanding, fast paced entrepreneurial environment
  • Sound judgment and business acumen with personal versatility and flexibility as business and team evolve
  • Keeps current on professional knowledge, expertise and best practice

Education and Experience:

  • BS or MS or PhD in Chemical Engineering, Chemistry or related discipline
  • BS and 8+ years of experience (6+ years with Masters, 4+ years with PhD)
  • Previous Experience working on process development, optimization and commercialization of drug products.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at